Helsinn and Fosun Pharma sign exclusive license and distribution agreements for Aloxi®, Akynzeo® oral, NEPA IV and anamorelin in Mainland China, Hong Kong SAR and Macau SAR — Helsinn

Lugano, Switzerland — Shanghai, China, October 12, 2021 — Helsinn Group (“Helsinn”), a Swiss Biopharmaceutical Group with an innovative R&D pipeline in cancer supportive care and oncology therapeutics, strategically investing in a fully integrated targeted therapy structure to develop, manufacture and commercialize small molecules in precision medicine with higher market potential, and Fosun Pharmaceutical A.G., a corporation organised and existing under the law of Switzerland and a wholly owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma), a leading global pharmaceutical and healthcare provider in China, announced today the signing of exclusive license and distribution agreements effective from October 1 st2021 in the territory of Mainland China for Aloxi ®, Akynzeo ®and anamorelin.

Under the terms of the agreements, Helsinn will grant Fosun Pharmaceutical A.G. an exclusive license to distribute, promote, market, and sell the following products in the aforesaid territory:

Approved products:

  • Aloxi®(Palonosetron hydrochloride) for the prevention of Chemotherapy Induced Nausea and Vomiting (CINV) and for Post-Operative Nausea and Vomiting
  • Akynzeo®oral (Netupitant and Palonosetron hydrochloride) for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and with moderately emetogenic cancer chemotherapy

Products under development

  • NEPA (Fosnetupitant and Palonosetron hydrochloride) IV, which is being developed in China for the prevention of CINV
  • anamorelin, a selective, novel, orally active ghrelin receptor agonist, which is being developed for the treatment of Malignancy Associated Weight Loss and Anorexia in non-small cell lung cancer patients

Helsinn will also grant Fosun Pharmaceutical A.G. an exclusive license for the said products in Hong Kong SAR and Macau SAR. In addition, Helsinn’s Chinese subsidiary, Helsinn Pharmaceuticals Beijing Co. Ltd. (HPC) will provide Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., a subsidiary company of Fosun Pharma with certain medical, marketing and commercial services, including co-promotion services in Shanghai, China, in support to the commercialization of the products in Mainland China, Hong Kong SAR and Macau SAR.

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: “Delivering therapies and supportive care to those living with cancer is at the core of what we do here at Helsinn, and we are pleased to have found a partner in Fosun Pharmaceutical A.G. that shares our values. Through these agreements we are able to provide patients across Mainland China and other territories with much needed therapies, targeting a variety of cancer-related illnesses and we look forward to working closely with Fosun Pharma in doing so.”

Wu Yifang, Chairman and CEO of Fosun Pharma, commented: “We are very pleased to sign this agreement with Helsinn. At Fosun, we are passionate about providing better health solutions for patients and these exclusive license and distribution agreements for Aloxi ®, Akynzeo ®and anamorelin across Mainland China, Hong Kong SAR and Macau SAR show our commitment to that mission. We are looking forward to working with Helsinn and to making these therapies available to patients in these territories as soon as possible.”

About Aloxi® in China

Palonosetron hydrochloride injection (strength: 5 ml/ 0.25 mg as Palonosetron) is indicated in adults for prevention of acute nausea and vomiting associated with Highly emetogenic cancer chemotherapy and Moderately emetogenic cancer chemotherapy. This product is indicated in pediatric patients aged 1 month to less than 17 years for: Prevention of acute nausea and vomiting associated with emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.

Palonosetron Hydrochloride Soft Capsules (0.5 mg as Palonosetron) is indicated for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Palonosetron hydrochloride injection (strength: 1.5 ml/0.075 mg as Palonosetron) is indicated in adults for prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.

About Akynzeo® oral in China

Netupitant and palonosetron hydrochloride capsules is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and with moderately emetogenic cancer chemotherapy.

NEPA (Fosnetupitant and Palonosetron hydrochloride) IV

The product containing 235 mg of fosnetupitant (equivalent to 260 mg fosnetupitant chloride hydrochloride) and 0.25 mg of palonosetron (equivalent to 0.28 mg of palonosetron hydrochloride) is being developed in China for prevention of acute and delayed nausea and vomiting associated with emetogenic cancer chemotherapy.

About anamorelin Anamorelin is a selective, novel, orally active ghrelin receptor agonist. Ghrelin is an endogenous peptide primarily secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, muscle mass, appetite and metabolism. Anamorelin is an investigational agent, which is being developed for the treatment of Malignancy Associated Weight Loss and Anorexia in non-small cell lung cancer patients. Anamorelin is not approved by the China National Medical Products Administration (“NMPA”).

Originally published at https://helsinn.com on October 12, 2021.

Swiss-Italian Pharmaceutical Entrepreneur Riccardo Braglia